search
Back to results

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

Primary Purpose

Pain, Postoperative, Nausea, Postoperative, Opioid Use

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Dexamethasone 4mg
NaCl 0.9%
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Age ≥ 18 years

    • general anasthesia
    • Elective isolated unilateral HAS for any reason
    • No Prior hip surgery
    • Written informed consent as documented by signature (Appendix Informed Consent Form)
    • Competent German language skills

Exclusion Criteria:

  • • Chronic pain patient, chronic lower back pain

    • Steroid or immunosuppressive drugs used within 6 months of surgery
    • Renal failure, hepatic failure
    • Relevant allergies
    • Pregnancy/ Breast feeding
    • Contraindications for Fortecortin treatment according to Swissmedic
    • Previous enrollment into the current study
    • Participation in another study with investigational drug within the 30 days preceding and during the present study
    • Known or suspected non-compliance, drug or alcohol abuse
    • Illness according to "Warnings and Precautions of Dexamethasone and NaCl"

Sites / Locations

  • Uniklinik Balgrist

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone group

Placebo/ Control group

Arm Description

The patients in the dexamethasone group will receive 12mg dexamethasone (Fortecortin ®) intravenously 15-60 minutes prior to surgery while in general anasthesia as well as 12mg dexamethasone intravenously (Fortecortin®) on the first postoperative day at approx. 8.00a.m. by the investigators.

The patients will not receive any additional drugs preoperatively. A 0.9% NaCl Solution (NaCl B. Braun Inf Lös 0.9 % 250ml Ecoflac plus®) will be administered at approx. 8.00 a.m. on the first postoperative day by the investigators.

Outcomes

Primary Outcome Measures

Postoperative pain level
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).
Postoperative pain level
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).
Amount of opiates (morphinequivalent) consumed
We will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.
Amount of anti-emetics consumed (Ondansetron)
We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.

Secondary Outcome Measures

Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Number of vomiting events
We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea.
Physical therapy milestones
Our patients will be instructed and perform different postoperative Rehabilitation steps including (first steps in the hallway, Walking up and down stairs, bicycle Ergometer)
Length of hospitalization
The length of hospitalization will be obtained from the Patient Chart.

Full Information

First Posted
October 6, 2020
Last Updated
September 22, 2023
Sponsor
Balgrist University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04610398
Brief Title
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy
Official Title
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy- a Double-blinded Placebo Controlled RCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy.
Detailed Description
Hip arthroscopy (HAS) is a standard procedure with good mid and long-term results. Postoperative pain is a great concern and postoperative pain management of great importance. High demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation. Promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement. It is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg Amp. Fortecortin =12mg prior to surgery and 3x4mg Amp. Fortecortin = 12mg at 8.00am of the first postoperative day in 250ml saline solution) to a control group (placebo) (1x 250ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction. A double-blinded prospective randomized control trial including 60 patients receiving elective unilateral HAS will be conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Nausea, Postoperative, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone group
Arm Type
Active Comparator
Arm Description
The patients in the dexamethasone group will receive 12mg dexamethasone (Fortecortin ®) intravenously 15-60 minutes prior to surgery while in general anasthesia as well as 12mg dexamethasone intravenously (Fortecortin®) on the first postoperative day at approx. 8.00a.m. by the investigators.
Arm Title
Placebo/ Control group
Arm Type
Placebo Comparator
Arm Description
The patients will not receive any additional drugs preoperatively. A 0.9% NaCl Solution (NaCl B. Braun Inf Lös 0.9 % 250ml Ecoflac plus®) will be administered at approx. 8.00 a.m. on the first postoperative day by the investigators.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4mg
Other Intervention Name(s)
Fortecortin Inject (Merck (Switzerland))
Intervention Description
s. arm/group description
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Other Intervention Name(s)
NaCL Braun (B.Braun Medical)
Intervention Description
s. arm/group description
Primary Outcome Measure Information:
Title
Postoperative pain level
Description
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).
Time Frame
6 hours postoperatively
Title
Postoperative pain level
Description
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain).
Time Frame
24 hours postoperatively
Title
Amount of opiates (morphinequivalent) consumed
Description
We will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.
Time Frame
48 hours postoperatively
Title
Amount of anti-emetics consumed (Ondansetron)
Description
We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.
Time Frame
48 houts postoperatively
Secondary Outcome Measure Information:
Title
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Description
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Time Frame
6 hours postoperatively
Title
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Description
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Time Frame
24 hours postoperatively
Title
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Description
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).
Time Frame
48 hours postoperatively
Title
Number of vomiting events
Description
We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea.
Time Frame
48 hours postoperatively
Title
Physical therapy milestones
Description
Our patients will be instructed and perform different postoperative Rehabilitation steps including (first steps in the hallway, Walking up and down stairs, bicycle Ergometer)
Time Frame
48 hours postoperatively
Title
Length of hospitalization
Description
The length of hospitalization will be obtained from the Patient Chart.
Time Frame
after 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Age ≥ 18 years general anasthesia Elective isolated unilateral HAS for any reason No Prior hip surgery Written informed consent as documented by signature (Appendix Informed Consent Form) Competent German language skills Exclusion Criteria: • Chronic pain patient, chronic lower back pain Steroid or immunosuppressive drugs used within 6 months of surgery Renal failure, hepatic failure Relevant allergies Pregnancy/ Breast feeding Contraindications for Fortecortin treatment according to Swissmedic Previous enrollment into the current study Participation in another study with investigational drug within the 30 days preceding and during the present study Known or suspected non-compliance, drug or alcohol abuse Illness according to "Warnings and Precautions of Dexamethasone and NaCl"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Zingg, MD
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik Balgrist
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If requested the individual participant data will be made available to other researchers.

Learn more about this trial

Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

We'll reach out to this number within 24 hrs